The rapid increase in the rate of caesarean section (CS) worldwide in recent decades has aroused great concern about the niche of caesarean section incision and its potential long-term complications. A niche is defined as an indentation in the myometrium at the site of the previous uterine cesarean scar with a depth of at least two mm. Among women with a history of CS, a niche is present in at lea
Conditions
Interventions
LNG-IUS group:LNG-IUS placement
Vaginal niche repair group:undergo vaginal niche repair surgery
Sponsors
The international peace maternity and child health hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Women (18–45 years); 2. Women having postmenstrual spotting after CS, defined as two or more days of intermenstrual spotting or as two or more days of brownish discharge immediately after the menstrual period in case the total period of the menstrual bleeding exceeds 7 days, if the period is shorter than 7 days the brownish discharge is considered to be normal; 3. Presence of a large symptomatic niche after caesarean section, defined as a niche with a depth of >50% of the total myometrial thickness at the anterior wall and with a maximum sagittal area >= 50 mm^2 using MRI; 4. Without a desire to conceive within 2 years; 5. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Women who has a positive urine pregnancy test. If the urine test cannot be confirmed as negative, a serum pregnancy test will be required; 2. Presence of an intrauterine device; 3. Women with a contraindication for a vaginal niche repair or LNG-IUS 52mg or not willing to receive this type of treatment. 4. Women with a contraindication to epidural or general anesthesia. 5. Coagulation disorders that lead to higher risk on bleeding, a (suspected) malignancy, submucosal fibroids, polyps, atypical endometrial cells, cervical dysplasia, cervical or pelvic infection, hydrosalpinx that communicates with the uterus; known endocrine disorders that interfere with the menstrual cycle; 6. Irregular menstrual cycle (>35 days or intercycle variation of 2 weeks or more) before the CS or currently an irregular (natural) cycle. 7. Refuse to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the total bleeding days of postmenstrual spotting symptoms associated with large niche; | — |
Countries
China
Contacts
Public ContactJian Zhang
The international peace maternity and child health hospital
Outcome results
None listed